A RCT Study in Schizophrenia Relapse Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Filip Spaniel, M.D., Ph.D, Prague Psychiatric Center
ClinicalTrials.gov Identifier:
NCT01885923
First received: August 14, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

THE AIM OF THE PROJECT The main aim lies in the prevention of frequent relapses typical for schizophrenia and schizoaffective disorder by means of simple, highly cost-effective information technology-aided approach RESEARCH HYPOTHESIS A the end of 18 months study duration, patients in the active group enrolled in ITAREPS will demonstrate statistically significantly reduced risk of hospitalization, decreased number of hospitalization days and reduced direct inpatient costs in comparison to control group not using the program.


Condition Intervention
Relapse Schizophrenia
Device: ITAREPS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Open, Controlled Study With Information and Telecommunication Technology-aided Relapse Prevention Program in Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Prague Psychiatric Center:

Primary Outcome Measures:
  • Primary Objective: The hospitalization-free survival rate at 18 months in active group compared to the control group. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of psychiatric hospitalization days [ Time Frame: 18months ] [ Designated as safety issue: No ]
  • Direct impatient costs [ Time Frame: 18months ] [ Designated as safety issue: No ]
  • Direct cost of outpatient antipsychotic medication [ Time Frame: 18months ] [ Designated as safety issue: No ]
  • Cumulative exposition to antipsychotic medication in both active ITAREPS and control groups [ Time Frame: 18months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20% antisychotic dose increase in prodromes
Antipsychotic dose increase upon prodromes occurence detected by Device- ITAREPS system. All antipsychotics currently registered in Czech Republic will be allowed in this study. All patients will remain on antipsychotic treatment adjusted prior enrollment, so that dose adjustment will be based on their ordinary medication. Participants will be instructed to complete the 10-item EWS Questionnaire upon SMS request sent automatically weekly to their mobile phones. EWSQ detects proportional worsening of the symptoms compared to the last week's score of the questionnaire. Individual EWSQ scores will be sent by participants back to the ITAREPS system as a SMS. If the total score exceeds the given score threshold, an immediate ALERT would be declared and announced to the investigator as an e-mail message and a therapeutic intervention is requested. After detecting the early warning signs by ITAREPS, an immediate 20% increase in the dose of antipsychotic will be required.
Device: ITAREPS
Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)
Other Name: Information Technology Aided Relaps Prevention in Schizophrenia
No Intervention: Treatment as usual
In the control group (treatment-as-usual) participants will not be enrolled in the ITAREPS system.

Detailed Description:

The ITAREPS 2.0 program employs telecommunication and information technologies in order to detect fluctuations in longitudinal mental health status of patient with schizophrenia and thus signalize the very early stages of prodromes preceding relapse. This approach opens an avenue towards early pharmacological intervention. Subjects (150 patients with diagnosis of schizophrenia and schizoaffective disorder and their family members) will be randomized at a 1:1 ratio into the active or control group. Participants from the active group will be completing two separate versions of the 10-item Early Warning Signs Questionnaire (EWSQ) upon a weekly SMS request generated automatically by the system during 18 months study duration. In this group, automatically generated e-mail alert message feedback to the investigator will be activated in case of prodrome detection, prompting investigator to antipsychotic dose increase by 20%. The control (treatment-as-usual) group will not use ITAREPS system.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For entry into the study, the following criteria MUST be met:

  • Men and women, ages 18 to 60 years, inclusive.
  • A diagnosis of schizophrenia or schizoaffective disorder according to ICD-10 classification.
  • Having at least TWO psychiatric hospitalization for psychosis before the study enrollment.
  • Severity (CGI-S) ≤ 3 at study Visit 1.
  • All patients must be on stable doses of antipsychotic medication during the study entry.

Exclusion Criteria:

  • Organic mental disorder,
  • mental disorder due to psychoactive substance use or mental retardation.
  • Participation in another relapse prevention program.
  • Hayward compliance rating scale score < 2 at Visit 1.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885923

Locations
Czech Republic
Prague Psychiatric Center
Prague, Czech Republic, 18103
Sponsors and Collaborators
Prague Psychiatric Center
Investigators
Study Director: Filip Spaniel, MD, PhD Prague Psychiatric Center
  More Information

Additional Information:
No publications provided

Responsible Party: Filip Spaniel, M.D., Ph.D, MD, Prague Psychiatric Center
ClinicalTrials.gov Identifier: NCT01885923     History of Changes
Other Study ID Numbers: ITAREPS 2.0, NT/13292 - 3
Study First Received: August 14, 2012
Last Updated: July 10, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Prague Psychiatric Center:
schizophrenia; relapse prevention; information technology

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014